The US Food and Drug Administration has begun accepting requests to participate in its newly launched PreCheck pilot programme, an initiative aimed at strengthening domestic pharmaceutical manufacturing and improving the resilience of the US drug supply chain.
Announced on February 1, 2026, the PreCheck programme is designed to enhance regulatory predictability, support the construction of new pharmaceutical manufacturing facilities in the United States, and streamline regulatory assessments well before a specific drug application is submitted. By enabling earlier engagement between manufacturers and regulators, the FDA aims to reduce uncertainty and accelerate the readiness of new facilities for commercial production.
As part of the pilot, the FDA will select an initial cohort of new pharmaceutical manufacturing sites and commence PreCheck activities during 2026. Facilities will be evaluated based on alignment with national priorities, including the type of products to be manufactured, the stage of facility development, timelines for supplying medicines to the US market, and the level of innovation in facility design and operations. Additional priority will be given to facilities focused on producing critical medications for the domestic market.
The programme’s structure reflects extensive feedback from industry stakeholders, gathered during the public meeting on onshoring drug and biological product manufacturing held in September 2025, as well as through public comments submitted via the Federal Register. Industry participants had emphasised the need for early regulatory engagement during facility development and more efficient documentation processes, both of which have been incorporated into the programme framework.
FDA PreCheck will be implemented in two phases. The first phase, known as the Facility Readiness Phase, allows selected manufacturers to engage with the agency before a facility becomes operational. This includes pre-operational reviews and the use of a facility-specific Drug Master File to enable early evaluation of manufacturing-related elements ahead of a formal drug application.
The second phase, the Application Submission Phase, builds on this early work through pre-submission meetings and inspections. This phase is intended to help resolve potential issues in advance and speed up the assessment of manufacturing information once a drug application is filed.
Through the PreCheck pilot, the FDA is seeking to support domestic manufacturing capacity while maintaining regulatory rigor, with the broader goal of improving supply chain security and access to essential medicines in the United States.
